Trial · NCT02174627
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis
NCT02174627, Phase 3, Completed, AstraZeneca; results first posted 2019-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis. Trials, record NCT02174627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02174627
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis
- NCT number
- NCT02174627
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,781 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Anemia
- Interventions
- Roxadustat, Placebo
- First posted
- 2014-06-25
- Last updated
- 2019-12-16
- Results first posted
- 2019-12-16
- Limitations and caveats
20 participants were excluded from the analysis due to Good Clinical Practice violations or system technical issues (9 in roxadustat group and 11 in placebo group). Higher IP discontinuation was observed in placebo group versus in roxadustat group.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 | Baseline (Day 1, Week 0) and Week 28 to Week 52. | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation analysis of covariance (ANCOVA) model with baseline Hb, baseline estimated glomerular filtration rate (eGFR), cardiovascular (CV) history, geographic region and treatment group as fixed effect covariates. The adjusted least squares (LS) mean estimates of change from baseline to mean during Week 28 to Week 52 are presented. |
| Secondary | Percentage of Participants With Hb Response During the First 24 Weeks of Treatment | Baseline (Day 1, Week 0) up to Week 24. | Hb response was defined as: * Hb ≥ 11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL for participants with baseline Hb \> 8.0 g/dL; or * Hb increase from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at 2 consecutive visits (with available data) separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (red blood cell \[RBC\] transfusion, erythropoietin analogue, or intravenous \[IV\] iron) prior to Hb response. The percentage of participants with an Hb response during the first 24 weeks of treatment is presented. |
| Secondary | Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0) and Week 28 to Week 52. | Baseline hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value during Week 28 to Week 52 was analyzed using a MAR based multiple imputation ANCOVA model with baseline Hb, baseline eGFR, CV history, geographic region and treatment group as fixed effect covariates. The adjusted LS mean estimates of change from baseline in participants with baseline hsCRP \>ULN to mean during Week 28 to Week 52 are presented. |
| Secondary | Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52 | Week 28 up to Week 52. | Proportion of total time of interpolated Hb values ≥10 g/dL was calculated as the time the linearly interpolated curve between measurements ≥10 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented. |
| Secondary | Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 | Week 28 up to Week 52. | Proportion of total time of interpolated Hb values within the interval of 10 to 12 g/dL was calculated as the time the linearly interpolated curve between measurements were within 10 to 12 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented. |
| Secondary | Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24 | Baseline (Day 1, Week 0) and Week 24 | Baseline LDL was defined as the last result obtained prior to randomization. Mean changes in LDL cholesterol from baseline to Week 24 was analyzed using an ANCOVA model with baseline LDL, baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented. |
| Secondary | Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy | Baseline (Day1, Week 0) up to End of Study (EOS) visit (4 weeks after the treatment period) (or up to date of first rescue therapy), with treatment duration up to 4 years. | Time-to-first rescue therapy (IV iron, RBC transfusion or erythropoietin analogue) was calculated as (date of first rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events. |
| Secondary | Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy | Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period) (or up to date of first RBC rescue therapy), with treatment duration up to 4 years. | Time-to-first RBC rescue therapy was calculated as (date of first RBC rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events. |
| Secondary | Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28 | Baseline (Day 1, Week 0) and Week 12 to Week 28. | SF-36 is a Quality of Life (QoL) scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Vitality sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a mixed model for repeated measures (MMRM) with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented. |
| Secondary | Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant | Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period), with treatment duration up to 4 years. | Baseline eGFR was defined as the mean of all available central laboratory values prior to or at randomization. Rate of change in eGFR from baseline during the entire treatment period (in millilitres/minute/1.73 meters squared/years \[mL/min/1.73m\^2/years\]) was estimated using a random effects model using all post-baseline eGFR values prior to initiation of dialysis/transplant. Baseline eGFR, baseline Hb, geographic region, CV history, treatment group and post-baseline eGFR measurement time were used as fixed effects and participant and time (years) as random effects, ie, random intercept and slope. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 | Baseline (Day 1, Week 0) and Week 28 to Week 52. | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hb Response During the First 24 Weeks of Treatment | Baseline (Day 1, Week 0) up to Week 24. | The Full Analysis Set (FAS) included all participants in the ITT analysis set who received at least 1 dose of IP and had baseline Hb and at least 1 post-dose Hb assessment. Participants from the FAS, with data available for analysis are presented. | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0) and Week 28 to Week 52. | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Only participants who consented to the use of donated biomarker samples and had baseline hsCRP \>ULN were included in the analysis. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52 | Week 28 up to Week 52. | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis. | proportion of total time | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 | Week 28 up to Week 52. | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis. | proportion of total time | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24 | Baseline (Day 1, Week 0) and Week 24 | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. | millimole per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy | Baseline (Day1, Week 0) up to End of Study (EOS) visit (4 weeks after the treatment period) (or up to date of first rescue therapy), with treatment duration up to 4 years. | The on-treatment plus 28 days (OT+28) analysis set included all participants who received at least 1 dose of randomized IP, except for those excluded from analysis. Participants were censored 28 days after last intake of IP. | Events per 100 participant years | NUMBER |
| SECONDARY | Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy | Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period) (or up to date of first RBC rescue therapy), with treatment duration up to 4 years. | The OT+28 analysis set included all participants who received at least 1 dose of randomized IP, except for those excluded from analysis. Participants were censored 28 days after last intake of IP. | Events per 100 participant years | NUMBER |
| SECONDARY | Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28 | Baseline (Day 1, Week 0) and Week 12 to Week 28. | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant | Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period), with treatment duration up to 4 years. | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. | eGFR rate (mL/min/1.73m^2/years) | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 | Roxadustat | 1.75 | Standard Error 0.033 | g/dL | |
| Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 | Placebo | 0.40 | Standard Error 0.034 | g/dL | |
| Percentage of Participants With Hb Response During the First 24 Weeks of Treatment | Roxadustat | 77.0 | Percentage of participants | ||
| Percentage of Participants With Hb Response During the First 24 Weeks of Treatment | Placebo | 8.5 | Percentage of participants | ||
| Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN) | Roxadustat | 1.75 | Standard Error 0.087 | g/dL | |
| Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN) | Placebo | 0.62 | Standard Error 0.091 | g/dL | |
| Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52 | Roxadustat | 0.82 | Standard Error 0.011 | proportion of total time | |
| Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52 | Placebo | 0.33 | Standard Error 0.011 | proportion of total time | |
| Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 | Roxadustat | 0.70 | Standard Error 0.010 | proportion of total time | |
| Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 | Placebo | 0.28 | Standard Error 0.010 | proportion of total time |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 1,384 | |
| Overall Study | STARTED | Placebo | 1,377 | |
| Overall Study | Received Treatment | Roxadustat | 1,384 | |
| Overall Study | Received Treatment | Placebo | 1,376 | |
| Overall Study | Discontinued Treatment | Roxadustat | 499 | |
| Overall Study | Discontinued Treatment | Placebo | 801 | |
| Overall Study | COMPLETED | Roxadustat | 1,300 | |
| Overall Study | COMPLETED | Placebo | 1,247 | |
| Overall Study | NOT COMPLETED | Roxadustat | 84 | |
| Overall Study | NOT COMPLETED | Placebo | 130 |
Source ClinicalTrials.gov
Adverse events1,548
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Roxadustat | 91 | 1,384 | 126 |
| other | Constipation | Gastrointestinal disorders | Placebo | 88 | 1,377 | 101 |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat | 138 | 1,384 | 190 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 117 | 1,377 | 156 |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 124 | 1,384 | 171 |
| other | Nausea | Gastrointestinal disorders | Placebo | 103 | 1,377 | 127 |
| other | Vomiting | Gastrointestinal disorders | Roxadustat | 75 | 1,384 | 90 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 67 | 1,377 | 85 |
| other | Oedema peripheral | General disorders | Roxadustat | 144 | 1,384 | 192 |
| other | Oedema peripheral | General disorders | Placebo | 106 | 1,377 | 135 |
1 to 10 of 1,548Source ClinicalTrials.gov
See all 1,548 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 284 | 1,384 |
| Total, all-cause mortality | Placebo | 245 | 1,377 |
| Total, other adverse events | Roxadustat | 839 | 1,384 |
| Total, other adverse events | Placebo | 757 | 1,377 |
| Total, serious adverse events | Roxadustat | 795 | 1,384 |
| Total, serious adverse events | Placebo | 749 | 1,377 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Roxadustat vs Placebo: deaths from any cause | Trial comparisons |
| Roxadustat vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02174627
GET https://conductscience.org/api/trials/v1/NCT02174627/results?page=2